327 Regulatory Submissions Jobs

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, industry standards.Develop and maintain relationships with regulatory authorities Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards. Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards.Develop and maintain relationships Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards. Excellent communication and interpersonal skills. Ability to work independently and as part of a team.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory medical writing or a related field. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.

JOB TITLE: Medical Device Regulatory Compliance Specialist JOB SUMMARY: We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to play a critical role in ensuring our medical device development processes meet the highest standards of quality and regulatory compliance. The ideal candidate will have hands-on experience with technical documentation, quality systems, and regulatory submissions, and will play a key role in ensuring product safety and compliance throughout the development lifecycle, specifically focusing on the Design History File (DHF) and Device Master Record (DMR). RESPONSIBILITIES: Support the preparation and maintenance of USFDA and EU MDR-comp...

This is an exciting role and would entail you to • Oversee the end-to-end submission process of materials to the MLR review platform (Veeva Vault Promo Mats) • Understand and document client-mandated submission requirements and ensure these protocols are maintained with guidance from MLR/Submission managers • Create, uphold, and maintain submission checklists for assigned brands and ensure accurate and timely MLR submissions into Client systems • Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines • Annotate any notes/comments relevant to MLR reviewers onto the submission file (As required, f...

About the Role We are seeking a SaMD QMS & Regulatory Expert to lead quality and regulatory activities with a specific focus on FDA compliance and IEC 62304 software lifecycle management. This role is central to ensuring that our Software as a Medical Device (SaMD) products meets all applicable U.S. FDA regulatory requirements while maintaining a robust, software-driven Quality Management System (QMS) that aligns with ISO 13485, ISO 14971 and FDAs requirements. The ideal candidate will have deep expertise in software lifecycle documentation, design controls, risk management, verification/validation, and regulatory submissions for software-based medical devices. The person should be someone w...

Role Overview: Preparation, review, and submission of responses to deficiency letters raised by the UK/EU regulatory agencies during the evaluation of Marketing Authorisation Applications (MAAs). The role ensures high-quality and compliant responses in line with regulatory expectations and timelines. Key Responsibilities: Coordinate with cross-functional teams (Development, Clinical, Nonclinical, Pharmacovigilance, Quality, Manufacturing, etc.) to obtain required information and justifications. Consolidate and review all data and documents to ensure consistency, accuracy, and regulatory compliance prior to submission. Draft and review responses addressing concerns on quality, safety, and eff...

Job Title Sr Regulatory Operation Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementa...

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

As a Global Strategy Leader for a pharmaceutical portfolio, you will play a crucial role in leading the strategic direction and execution of regulatory strategies. Your responsibilities will include: - Developing global regulatory strategies for the company's pharmaceutical portfolio, such as IND/CTAs, NDAs, NDSs, MAAs, and other key regulatory submissions. - Collaborating with senior leadership in various functional areas to align regulatory strategy with overall product development and business objectives. - Providing expert guidance on regulatory requirements, market access strategies, and potential risks to inform decision-making across the organization. - Overseeing the planning, prepar...

Role Overview: You will be responsible for managing a team of regulatory specialists and ensuring timely regulatory submissions to support study start up. As a Manager at Velocity Clinical Research, you will proactively address challenges, drive efficiency, and provide guidance on regulatory compliance. Key Responsibilities: - Manage a team of regulatory specialists to ensure timely and efficient regulatory submissions. - Prepare study-specific documents such as protocols, informed consent forms, and HIPAA authorizations for review by the IRB. - Submit and manage amendments, adverse event reports, and other IRB-required submissions. - Provide guidance on conflict of interest paperwork and ma...

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying up...

As a Medical Information Specialist at the company, your main responsibilities will include: - Responding to medical information queries, product quality complaints, and general queries received through telephone calls, email, fax, etc. - Receiving, recording, and reporting Adverse Drug Reactions in a timely manner as per regulations and internal WI/SOPs. - Executing drug safety data management processes including call intake, dialogue documentation, peer review, and case follow-up. - Performing various assigned activities such as tracking information and metrics, ongoing quality control of process steps, training, and data reconciliation. - Creating and updating training materials based on ...

About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (L...

Company Description Hayai Pharma is the Exporter of finished formulation of medicines accross various geographies. Role Description This is a full-time on-site role for a Senior Manager Regulatory Affairs, based in Meerut, Delhi NCR. The Senior Manager Regulatory Affairs will be responsible for preparations of filings for product or site registration in the target market. This would include compilation of dossiers, coordination with stakeholders and other allied activities. Prior experience of 5 years in the same field is a must Qualifications Experience in Regulatory Affairs and Regulatory Submissions Knowledge of Quality Systems Strong analytical and problem-solving skills Excellent writte...

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure alignment with cGMP, ICH Q7, and ...

Role Overview: You will be joining Driffle, a global digital goods marketplace that specializes in digital gaming products and operates in 140 countries. Your role will involve supporting the drafting and review of internal policies, terms and conditions, and compliance-related documentation. Additionally, you will assist in maintaining records of licenses, filings, and regulatory submissions across various jurisdictions. Your responsibilities will also include preparing reports and presentations for stakeholders. Key Responsibilities: - Support the drafting and review of internal policies, terms and conditions, and compliance-related documentation. - Help maintain up-to-date records of lice...

Role & responsibilities Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain well-organized records of submissions, ...

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission Preparation of respective CTD sections and submission of final query response to agency Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval To upload documents in national portal for respective European regulatory agency Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation Review of the mockups for all regulatory submissions and commercial supplies Maintenance of internal database Co-ordination with consulta...

Role Overview: You will lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Your responsibilities include end-to-end report management, planning, authoring, managing review and submission steps, applying safety domain knowledge, managing deliverables of medium to high complexity, and ensuring timely delivery of high-quality documents to internal customers and sponsors/clients. You will coordinate activities related to several types of report writing across a team of writers, perform support activities such as tracking, maintenance of metrics, quality checks, and training, and assist Medical Writers in preparing safety r...

As a Senior Compliance Professional at Aikyam Capital, you will play a crucial role in ensuring trust, governance, and integrity through compliance practices. Your responsibilities and qualifications are outlined below: Role Overview: - Lead and manage compliance programs across multiple verticals - Ensure adherence to SEBI, Exchange regulations, and internal policies - Review SOPs, policies, agreements to align with compliance standards - Drive internal audits, risk assessments, and training initiatives - Oversee regulatory submissions, CTCL, ALGO, COLO, and exchange approvals - Act as the key liaison between leadership, regulators, and industry bodies Key Responsibilities: - CS and/or LLB ...

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

As a Clinical Trials Assistant, your role will involve assisting in the preparation and coordination of clinical trial protocols and associated documents. You will support the monitoring of clinical trials at various stages, including site initiation, maintenance, and close-out. Your responsibilities will include ensuring that study sites are compliant with Good Clinical Practice (GCP) and regulatory requirements. Additionally, you will conduct site visits to assess the progress of clinical trials, monitor data accuracy, and ensure patient safety. Key Responsibilities: - Assist in the review and management of clinical trial documentation, including case report forms (CRFs), informed consent ...